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An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

Phase 2
18 Years
Open (Enrolling)
Relapsed or Plateau-Phase Multiple Myeloma

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Trial Information

An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

Patients who have relapsed myeloma have failed treatment regimens and have had disease
progression following their last treatment regimen. Despite newer salvage therapies, their
treatment options are limited and may include best supportive care and investigational
therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without
further tumor regression despite continued treatment. Recent evidence suggests that their
prognosis might improve with further reduction in serum M-protein or prolongation of time to
disease progression (TTP). These patients are candidates for investigational agents that
could further reduce tumor burden or increase TTP.

Inclusion Criteria:

- age ≥ 18 years

- clinical diagnosis of relapsed or plateau-phase multiple myeloma

- measurable disease (>0.5 g/dL) as determined by special blood tests

- ECOG 0 or 1

Exclusion Criteria:

- newly diagnosed myeloma

- non-secretory myeloma

- plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome

- prior allogeneic stem cell transplant

- administration of oral or IV bisphosphonates within 2 weeks of enrollment to study

Other criteria also apply.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response or Partial Response Based on M-Protein Assessments Only

Outcome Description:

Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.

Outcome Time Frame:

Up to 18 months

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Australia: Therapeutic Goods Administration

Study ID:




Start Date:

November 2005

Completion Date:

February 2012

Related Keywords:

  • Relapsed or Plateau-Phase Multiple Myeloma
  • Multiple Myeloma, Relapsed, Plateau-Phase
  • Multiple Myeloma
  • Neoplasms, Plasma Cell